Zidovudine treatment of the AIDS dementia complex: Results of a placebo‐controlled trial Journal Article
| Authors: | Sidtis, J. J.; Gatsonis, C.; Price, R. W.; Singer, E. J.; Collier, A. C.; Richman, D. D.; Hirsch, M. S.; Schaerf, F. W.; Fischl, M. A.; Kieburtz, K.; Simpson, D.; Koch, M. A.; Feinberg, J.; Dafni, U.; and the AIDS Trials Group |
| Article Title: | Zidovudine treatment of the AIDS dementia complex: Results of a placebo‐controlled trial |
| Abstract: | The efficacy of two doses of zidovudine was examined for the treatment of the acquired immunodeficiency syndrome (AIDS) dementia complex in a randomized, double‐blinded, placebo‐controlled trial conducted at nine study centers. For the initial 16 weeks, 40 subjects with mild to moderate AIDS dementia complex were randomized to one of three treatment arms: 400 mg of zidovudine five times daily, 200 mg of zidovudine five times daily, or placebo five times daily. After week 16, patients initially randomized to the placebo group were rerandomized to one of the two zidovudine treatment arms. The primary efficacy end point was improvement in performance on a battery of seven neuropsychological tests; the secondary end point was improvement on a protocol neurological evaluation directed at the cardinal features of the AIDS dementia complex. For the initial 16‐week period, average z scores based on the neuropsychological test battery revealed a significant improvement in the combined treatment groups compared to the placebo group; however, when the two treatment groups were compared separately to the placebo group, only the group receiving the higher zidovudine dose exhibited significant improvement. After rerandomization of the placebo patients to one of the two treatment arms at week 16, this group also showed significant improvement in the average neuropsychological z score by week 32. These results extend previous observations that indicate a therapeutic benefit of zidovudine for the treatment of AIDS dementia complex. Copyright © 1993 The American Neurological Assosiation |
| Keywords: | adult; clinical article; controlled study; treatment outcome; placebo; dose response; drug efficacy; human immunodeficiency virus infection; follow-up studies; phase 2 clinical trial; time factors; dementia; neuropsychological tests; acquired immune deficiency syndrome; psychologic test; oral drug administration; zidovudine; middle age; human; male; female; priority journal; article; support, u.s. gov't, p.h.s.; aids dementia complex |
| Journal Title: | Annals of Neurology |
| Volume: | 33 |
| Issue: | 4 |
| ISSN: | 0364-5134 |
| Publisher: | Wiley Blackwell |
| Date Published: | 1993-04-01 |
| Start Page: | 343 |
| End Page: | 349 |
| Language: | English |
| DOI: | 10.1002/ana.410330403 |
| PUBMED: | 8489204 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Source: Scopus |
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